The Recall Desk
ModerateFDA (Devices)·Z-1131-2023·Announced 2023-02-22

HydroPICC Catheters Recalled for Incorrect Expiration Date Labeling

Access Vascular, Inc is recalling HydroPICC 4Fr Single Lumen catheters (Model 80001001) due to incorrect expiration date labeling. The devices expire earlier than the labeled date.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This recall is classified as Moderate severity. The devices are subject to FDA Class II classification, but no reported injuries or hospitalizations have been documented. The issue is incorrect expiration date labeling, which is a labeling error rather than a structural defect in the catheter itself.

Plain-English summary

Access Vascular, Inc has recalled HydroPICC 4Fr Single Lumen, 130cm Guidewire - Basic Kit (Model Number 80001001) due to incorrect expiration date labeling. Select catheter lots were labeled with expiration dates that are later than the actual expiration date of the devices.

The recall affects 302 HydroPICC devices distributed nationwide to healthcare facilities in Connecticut, Illinois, Indiana, Massachusetts, Nebraska, Tennessee, and Texas. Affected lot numbers are 11398679 and 11416178.

Using expired catheters could result in device malfunction or reduced performance during medical procedures. Healthcare providers and facilities should immediately stop using any remaining units from the recalled lots and dispose of them according to medical waste procedures.

For more information, healthcare providers should contact Access Vascular, Inc through the FDA at the recall reference number Z-1131-2023.

The recalled product

Product
HydroPICC 4Fr Single Lumen, 130cm Guidewire - Basic Kit, Model Number 80001001
Manufacturer
Access Vascular, Inc
Category
Medical Device — Vascular Access / Catheter
Hazard
Affected units
302

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • UDI-DI: (01)00862559000456
  • Lot Number: 11398679
  • 11416178

Distribution

Distributed nationwide across the United States.

The notice also names 7 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Access Vascular, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · Access Vascular, Inc

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Same hazard · mis labeling

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